K823569 is an FDA 510(k) clearance for the ABBOTT LABORATORIES STREP A EIA. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 1, 1983, 88 days after receiving the submission on December 3, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K823569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1982 |
| Decision Date | March 01, 1983 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GTZ — Antisera, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |